Actively Recruiting
Performance Analysis of Hermetic Closed-loop Anesthesia Delivery System
Led by Sir Ganga Ram Hospital · Updated on 2026-04-27
150
Participants Needed
1
Research Sites
151 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Total intravenous anaesthesia (TIVA) is now a preferred technique for providing general anaesthesia (GA) because of its various inherent advantages like reduced postoperative nausea and vomiting (PONV), improved quality of post-operative recovery, anti-inflammatory and antioxidant action, anti-neoplastic activity, analgesic action, and absence of greenhouse effect. The evolution and advancement in automated anaesthesia delivery systems particularly for propofol have made propofol-TIVA more efficient by removing the human interface for both rate and concentration adjustments. Automated computer-controlled closed loop anaesthesia device adjusts propofol delivery based on patient's frontal cortex electrical activity determined by bispectral index (BIS). Closed loop anaesthesia delivery system (CLADS) is an indigenously developed patented (Patent no.502/DEL/2003 \& US 9,108,013 B2) computer-controlled anaesthesia delivery system which works with feedback loop information elicited by BIS monitoring and delivers propofol TIVA to the patient via a non-TCI automated infusion pump. It has been an extensively used and validated in patients undergoing both cardiac and non-cardiac surgical procedures. A new compact and upgraded version of CLADS is now available. This new version incorporates the anesthetic depth monitor, hemodynamic monitor, controller, user interface and actuator syringe pump into a single, compact and user-friendly module. The investigators aim to conduct a prospective randomized pilot study comparing the new CLADS and older CLADS version with respect to: adequacy of anaesthesia depth maintenance, performance characteristic of propofol delivery system, propofol requirement, haemodynamics stability, recovery from anesthesia and postoperative sedation.
CONDITIONS
Official Title
Performance Analysis of Hermetic Closed-loop Anesthesia Delivery System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 65 years
- ASA physical status I-II
- Undergoing elective non-cardiac surgery lasting at least 60 minutes
You will not qualify if you...
- Uncompensated cardiovascular disease such as uncontrolled hypertension, atrioventricular block, sinus bradycardia, congenital heart disease, reduced left ventricular compliance, or diastolic dysfunction
- Hepato-renal insufficiency
- History of neurological disorders such as epilepsy or brain trauma
- Uncontrolled endocrine diseases like diabetes mellitus or hypothyroidism
- Known allergy or hypersensitivity to the study drug
- History of psychiatric disorders or drug dependence/substance abuse
- Requirement for postoperative ventilation
- Refusal to give informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Nitin Sethi
New Delhi, National Capital Territory of Delhi, India, 110060
Actively Recruiting
Research Team
A
Amitabh Dutta, MD, PGDHR
CONTACT
N
Nitin Sethi, DNB
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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